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FDA 510(k)

RESPIRATION MONITOR TYPE MR-10

K-Number: K822077 · 1982-10-06

ApplicantNew Dimensions IN Medicine, Inc.
Decision Date1982-10-06
Product CodeFLS
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIRATION MONITOR TYPE MR-10 is the device name listed in this FDA 510(k) record. The listed applicant is New Dimensions IN Medicine, Inc.. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822077. The device is classified under product code FLS. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIRATION MONITOR TYPE MR-10?

RESPIRATION MONITOR TYPE MR-10 is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is New Dimensions IN Medicine, Inc.. The 510(k) number is K822077.

When did RESPIRATION MONITOR TYPE MR-10 receive FDA 510(k) clearance?

RESPIRATION MONITOR TYPE MR-10 received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822077.

Who is the listed applicant for RESPIRATION MONITOR TYPE MR-10?

The FDA 510(k) record lists New Dimensions IN Medicine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIRATION MONITOR TYPE MR-10?

The FDA product code for RESPIRATION MONITOR TYPE MR-10 is FLS.

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Other records listing New Dimensions IN Medicine, Inc. as applicant

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Related Devices (Code: FLS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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